Device recall

Z-0462-03: Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with…

FDA device recall · Class II · Novoste Corporation

Key facts

Recall number (Z-number) Z-0462-03
Recall event 25139
Product Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.
Product code JAJ
Recalling firm Novoste Corporation
Recall class Class II
Status Terminated
Termination date Nov 17, 2003
FEI number 3000205626

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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